Senior Quality Engineer: Lead Quality Systems & Compliance

Lubrizol Health; Corona (CA); On-site; USD 135,000 - 145,000; Full time

Benefits offered by this job

Competitive salary

401(k) match

Medical, dental & vision

HSA

Paid holidays & vacation

Flexible work environment

Learning and development

Career growth

Inclusive culture

Job summary

Lubrizol Corporation seeks a Senior Quality Engineer to drive quality systems, risk management, validation, and process controls across the product lifecycle. The role requires cross-functional influence, mentorship, and commitment to regulatory compliance including ISO 13485, CFR 21 Part 820, and EU MDR.

You will lead audits, CAPA activities, supplier quality programs, and continuous improvement initiatives in a fast-paced, manufacturing-focused environment.

Qualifications

• 5+ years in Quality Engineering within a regulated medical device environment.
• Experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971 and EU MDR.
• Ability to lead verification/validation activities and risk management.
• Strong problem-solving, data analysis, and process improvement skills.

Responsibilities

• Lead QA systems, risk management, validation, and process controls for quality improvements.
• Provide QA leadership for NPI, manufacturing process development, and transfers.
• Develop and execute IQ/OQ/PQ protocols and related reports.
• Lead investigations for nonconformances and CAPAs with root-cause analysis.
• Drive cross-functional problem-solving using FMEA, 5 Whys, DOE, SPC and statistics.

Skills

Quality Engineering

Regulatory knowledge

Root cause analysis

FMEA

DOE

Statistical analysis

Problem solving

Leadership

Supplier quality

Process improvement

Education

Bachelor’s degree in engineering

Master's degree preferred

Tools

Minitab

JMP

Job description

Lubrizol Corporation seeks a Senior Quality Engineer to drive quality systems, risk management, validation, and process controls across the product lifecycle. The role requires cross-functional influence, mentorship, and commitment to regulatory compliance including ISO 13485, CFR 21 Part 820, and EU MDR.

You will lead audits, CAPA activities, supplier quality programs, and continuous improvement initiatives in a fast-paced, manufacturing-focused environment.